Actively Recruiting
Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
Led by Gulam Manji · Updated on 2025-06-19
10
Participants Needed
3
Research Sites
403 weeks
Total Duration
On this page
Sponsors
G
Gulam Manji
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if it's safe. The treatment consists of standard chemotherapy (gemcitabine and nab-paclitaxel) which is FDA approved and is standard treatment for patients with pancreatic adenocarcinoma. Participants will receive immunotherapy (cemiplimab) which activates the body's immune system to attack cancer cells. Cemiplimab is FDA approved for treatment of skin cancer but not for pancreas cancer. Participants will also receive Motixafortide, a new medication which has shown in the laboratory to help immunotherapy work better. Motixafortide has been tested together with immunotherapy (Pembrolizumab), and chemotherapy (5-Fluorouracil and liposomal Irinotecan) and was deemed safe to test additional patients. Motixafortide has not been tested with the specific immunotherapy (Cemiplimab) and chemotherapy (gemcitabine and nab-paclitaxel) which participants will receive and is being tested in this clinical trial.
CONDITIONS
Official Title
Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or pathological confirmation of metastatic pancreas adenocarcinoma verified by biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age 18 years or older
- Adequate blood counts and organ function within 14 days prior to treatment
- Measurable disease accessible for biopsy
- Negative pregnancy test for women of child-bearing potential and agreement to use effective contraception
- Fertile men must agree to use effective birth control during and for 3 months after treatment
- Ability and willingness to provide written informed consent and comply with study protocols
- Underwent testing to rule out deep venous thrombosis and stable anticoagulation if present
- Stable full-dose anticoagulation allowed with principal investigator approval for increased clot burden
You will not qualify if you...
- Prior systemic therapy, investigational therapy, or immune checkpoint therapy for pancreatic cancer
- Radiation therapy within 2 weeks prior to treatment, except for pain palliation
- Prior pancreatic cancer surgery
- Current use of other investigational agents
- Unresolved severe side effects from prior cancer treatments except alopecia or mild peripheral neuropathy
- Use of other anti-cancer agents besides hormone therapy
- Uncontrolled pleural, pericardial effusion, or ascites requiring drainage
- Uncontrolled tumor-related pain or unstable narcotic regimen
- History of brain or central nervous system metastases
- Uncontrolled or symptomatic hypercalcemia
- Recent major surgery or significant injury within 14 days
- Active or past autoimmune diseases except well-controlled hypothyroidism, diabetes, or limited dermatologic conditions
- History or evidence of lung diseases like pulmonary fibrosis or active pneumonitis
- Positive HIV test or active hepatitis B or C infection
- Significant liver disease or active tuberculosis
- Severe infections requiring antibiotics within 2 weeks prior
- Significant cardiovascular disease or unstable heart conditions
- Low heart function or prolonged QT interval on ECG
- Recent major bleeding events
- Prior stem cell or organ transplantation
- Other recent malignancies within 2 years except low risk types
- Recent live vaccine administration
- Severe allergies to study drugs
- Recent immunosuppressive treatments except certain exceptions
- Pregnancy or breastfeeding
- Other conditions deemed high risk or contraindications by investigator
- Uncontrolled psoriasis, porphyria, myopathy, or neuropathy
- Severe depression or recent hospitalization for psychiatric illness
- Recent blood transfusions within 4 weeks
- Use of high-dose corticosteroids exceeding allowed limits prior to treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
2
Brown University
Providence, Rhode Island, United States, 02912
Actively Recruiting
3
Medical College of Wisconsin, Wisconsin Diagnostic Labratories
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
R
Research Nurse Navigator
CONTACT
G
Gulam Manji, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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